Accommodating intraocular lenses and methods of use

ABSTRACT

Accommodating intraocular lenses and methods of use. The accommodating intraocular lenses include peripheral regions that are adapted to be more responsive to certain types of forces than to other types of forces. For example, the accommodating intraocular lenses can include haptics that are stiffer in an anterior-to-posterior direction than in a radial direction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/672,608, filed Nov. 8, 2012, which is a continuation-in-part of U.S.application Ser. No. 12/685,531, filed Jan. 11, 2010, now abandoned,which claims the benefit of U.S. Provisional Application No. 61/143,559,filed Jan. 9, 2009, all of which are incorporated by reference herein.

U.S. application Ser. No. 13/672,608, filed Nov. 8, 2012, also claimsthe benefit of U.S. Provisional Application No. 61/557,237, filed Nov.8, 2011, which is incorporated by reference herein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

The crystalline lens is a transparent, biconvex structure in the eyethat, along with the cornea, helps to refract light to be focused on theretina. The crystalline lens, by changing shape, functions to change thefocal distance of the eye so that it can focus on objects at variousdistances. This adjustment of the crystalline lens is known asaccommodation. The lens capsule is a smooth, transparent membrane thatcompletely surrounds the lens. The lens capsule is elastic and iscomposed of collagen. The lens is flexible and its curvature iscontrolled by ciliary muscles through the zonules, which connect theciliary muscles and the equatorial region of the capsule. At short focaldistance the ciliary muscle contracts, the zonules loosen, and the lensthickens, resulting in a rounder shape and thus high refractive power.Changing focus to an object at a greater distance requires therelaxation of the ciliary muscle, which increases the tension on thezonules, flattening the lens and thus increasing the focal distance.

A crystalline lens can be removed and replaced with an artificial lens,generally referred to as an intraocular lens, for a variety of reasons.Some intraocular lenses are used to replace a cataract lens, a cloudingthat develops in the crystalline lens of the eye, obstructing thepassage of light. Intraocular lenses can be characterized asnon-accommodating or accommodating. Accommodating intraocular lenses aredesigned to function similarly to the native crystalline lens and areadapted to change power to provide near and distance vision.

The native crystalline lens is typically removed through a procedurereferred to as an extracapsular extraction. The procedure includesmaking a capsulorhexis, a circular incision made on the anterior side ofthe capsule, followed by removal of the lens material. The replacementintraocular lens can then be positioned within the capsule through theopening formed by the circular incision.

As is set forth in more detail in U.S. application Ser. No. 12/685,531,filed Jan. 11, 2010, from which this application claims priority, thereis patient-to-patient variability in capsular bag size, there areimperfect techniques for measuring capsular sizes, and there arepost-implant changes that can occur within the eye or to theaccommodating intraocular lens. Accommodating intraocular lenses aredesired for which the base state, or base power (which may also bereferred to herein as “set-point”), of the accommodating intraocularlens is more predictable after implanting it within an eye, and yet willstill accommodate in response to ciliary muscle movement.

SUMMARY OF THE DISCLOSURE

One aspect of the disclosure is an accommodating intraocular lenscomprising an optic portion comprising an optic fluid chamber; and aperipheral non-optic portion secured to and extending peripherally fromthe optic portion, the peripheral non-optic portion comprising aperipheral fluid chamber in fluid communication with the optic fluidchamber, wherein the peripheral non-optic portion is adapted to deformin response to forces on the peripheral non-optic portion due to ciliarymuscle movement to thereby move a fluid between the peripheral fluidchamber and the optic fluid chamber to change an optical parameter ofthe accommodating intraocular lens, wherein the peripheral non-opticportion is adapted to be more sensitive to forces in the radialdirection that it is to forces in the anterior-to-posterior direction.

In some embodiments the peripheral non-optic portion is adapted todeform in response to capsular bag forces on the peripheral non-opticportion due to ciliary muscle movement to thereby move a fluid betweenthe peripheral fluid chamber and the optic fluid chamber to change anoptical parameter of the accommodating intraocular lens.

In some embodiments the peripheral non-optic portion is adapted to bemore sensitive to capsular bag forces in the radial direction than it isto capsular bag forces in the anterior-to-posterior direction.

In some embodiments the peripheral non-optic portion is adapted todeform more in response to forces in the radial direction that it is toforces in the anterior-to-posterior direction.

In some embodiments the peripheral non-optic portion is adapted suchthat a greater volume of fluid moves between the peripheral fluidchamber and the optic fluid chamber in response to forces on theperipheral non-optic portion in the radial direction that in response toforces on the peripheral non-optic portion in the anterior-to-posteriordirection.

In some embodiments the peripheral non-optic portion is stiffer in theanterior-to-posterior direction that it is in the radial direction. Theperipheral non-optic portion can comprise a radially outer body portionadapted to be disposed adjacent a radial portion of the capsular bag,and a radially inner body portion that has a radial thickness greaterthan a radial thickness of the radial outer body portion, wherein in therelative thicknesses adapt the peripheral non-optic portion to be moresensitive to capsular forces in the radial direction than to capsularforces anterior-to-posterior direction.

In some embodiments, in a cross section of the peripheral non-opticportion in a plane that extends in the anterior-to-posterior direction,an outer surface of the peripheral portion has an axis of symmetry, andwherein the peripheral fluid chamber in the cross section is notsymmetrical along the axis of symmetry. The outer surface can have agenerally oval configuration. In the cross section the peripheral fluidchamber can have a radially inner surface that is more linear than aradially outer surface.

One aspect of the disclosure is an accommodating intraocular lenscomprising an optic portion comprising an optic fluid chamber; and aperipheral non-optic portion secured to and extending peripherally fromthe optic portion, the peripheral non-optic portion comprising aperipheral fluid chamber in fluid communication with the optic fluidchamber, wherein the peripheral non-optic portion is adapted to deformin response to forces on the peripheral non-optic portion due to ciliarymuscle movement to thereby move a fluid between the peripheral fluidchamber and the optic fluid chamber to change an optical parameter ofthe accommodating intraocular lens, and wherein the peripheral non-opticportion has a stiffness in the anterior-to-posterior direction that isdifferent than a stiffness in the radial direction.

In some embodiments the stiffness in the anterior-to-posterior directionis greater than the stiffness in the radial direction.

In some embodiments the peripheral non-optic portion is adapted todeform in response to capsular bag forces on the peripheral non-opticportion due to ciliary muscle movement to thereby move a fluid betweenthe peripheral fluid chamber and the optic fluid chamber to change anoptical parameter of the accommodating intraocular lens.

In some embodiments the peripheral non-optic portion is adapted to bemore sensitive to forces in the radial direction than it is to forces inthe anterior-to-posterior direction.

In some embodiments the peripheral non-optic portion is adapted todeform more in response to forces in the radial direction that it is toforces in the anterior-to-posterior direction.

In some embodiments the peripheral non-optic portion is adapted suchthat a greater volume of fluid moves between the peripheral fluidchamber and the optic fluid chamber in response to forces on theperipheral non-optic portion in the radial direction that in response toforces on the peripheral non-optic portion in the anterior-to-posteriordirection.

One aspect of the disclosure is an accommodating intraocular lenscomprising an optic portion comprising an optic fluid chamber; and aperipheral non-optic portion secured to and extending peripherally fromthe optic portion, the peripheral non-optic portion comprising aperipheral fluid chamber in fluid communication with the optic fluidchamber, wherein the peripheral non-optic portion is adapted to deformin response to forces on the peripheral non-optic portion due to ciliarymuscle movement to thereby move a fluid between the peripheral fluidchamber and the optic fluid chamber to change an optical parameter ofthe accommodating intraocular lens, and wherein a first volume of fluidmoved between the peripheral fluid chamber and the optic fluid chamberin response to forces on the peripheral non-optic portion in theanterior-to-posterior direction is less than a second volume of fluidmoved between the peripheral fluid chamber and the optic fluid chamberin response to forces on the peripheral non-optic portion in the radialdirection.

In some embodiments the peripheral non-optic portion is adapted todeform in response to capsular bag forces on the peripheral non-opticportion due to ciliary muscle movement to thereby move a fluid betweenthe peripheral fluid chamber and the optic fluid chamber to change anoptical parameter of the accommodating intraocular lens.

In some embodiments the peripheral non-optic portion is adapted to bemore sensitive to capsular bag forces in the radial direction than it isto capsular bag forces in the anterior-to-posterior direction.

In some embodiments the peripheral non-optic portion is adapted todeform more in response to forces in the radial direction that it is toforces in the anterior-to-posterior direction.

In some embodiments the peripheral non-optic portion is stiffer in theanterior-to-posterior direction that it is in the radial direction. Theperipheral non-optic portion comprises a radially outer body portionadapted to be disposed adjacent a radial portion of the capsular bag,and a radially inner body portion that has a radial thickness greaterthan a radial thickness of the radial outer body portion, wherein in therelative thicknesses adapt the peripheral non-optic portion to be moresensitive to capsular forces in the radial direction than to capsularforces anterior-to-posterior direction.

One aspect of the disclosure is an accommodating intraocular lens,comprising an optic portion comprising an optic fluid chamber; and aperipheral non-optic portion secured to and extending peripherally fromthe optic portion, the peripheral non-optic portion comprising aperipheral fluid chamber in fluid communication with the optic fluidchamber, wherein the peripheral non-optic portion is adapted to deformin response to forces on the peripheral non-optic portion due to ciliarymuscle movement to thereby move a fluid between the peripheral fluidchamber and the optic fluid chamber to change an optical parameter ofthe accommodating intraocular lens, wherein the peripheral non-opticportion is adapted to resist deformation from capsular forces in theanterior-to-posterior direction more than deformation from capsularforces in the radial direction.

One aspect of the disclosure is an accommodating intraocular lens,comprising an optic portion comprising an optic fluid chamber; and aperipheral non-optic portion secured to and extending peripherally fromthe optic portion, the peripheral non-optic portion comprising aperipheral fluid chamber in fluid communication with the optic fluidchamber, wherein the peripheral non-optic portion is adapted to deformin response to forces on the peripheral non-optic portion due to ciliarymuscle movement to thereby move a fluid between the peripheral fluidchamber and the optic fluid chamber to change an optical parameter ofthe accommodating intraocular lens, wherein the peripheral non-opticportion is adapted to reconfigure the capsule to a configuration inwhich the capsule extends further in the anterior-to-posterior directionthat in a native configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate an exemplary accommodating intraocular lens.

FIG. 1C illustrates a sectional view of the accommodating intraocularlens from FIGS. 1A and 1B.

FIG. 1D is a top view of an exemplary posterior element of anaccommodating intraocular lens.

FIG. 1E is a sectional assembly view of an exemplary optic portion of anaccommodating intraocular lens.

FIGS. 1F and 1G illustrate an exemplary haptic.

FIG. 1H illustrates an exemplary coupling between an optic portion and ahaptic.

FIGS. 2A-2C illustrate an exemplary haptic.

FIGS. 2D-2F illustrate sectional views of the haptic from FIG. 2A.

FIG. 2G illustrates an opening in a first end of the haptic from FIGS.2A-2C.

FIG. 3 illustrates exemplary diameters of an accommodating intraocularlens.

FIG. 4 illustrates an exemplary haptic.

FIGS. 5A and 5B illustrate the deformation of an exemplary haptic inresponse to exemplary forces.

FIG. 6 illustrates an exemplary fluid opening in an exemplary haptic.

FIG. 7 illustrates an exemplary fluid opening in an exemplary haptic.

FIG. 8 illustrates a sectional view of an exemplary accommodatingintraocular lens.

FIG. 9 illustrates a sectional view of an exemplary accommodatingintraocular lens with relatively short haptics.

DETAILED DESCRIPTION

The disclosure relates generally to accommodating intraocular lenses. Insome embodiments the accommodating intraocular lenses described hereinare adapted to be positioned within a native capsular bag in which anative lens has been removed. In these embodiments a peripheralnon-optic portion (i.e., a portion not specifically adapted to focuslight on the retina) is adapted to respond to capsular bag reshaping dueto ciliary muscle relaxation and contraction. The response is adeformation of the peripheral portion that causes a fluid to be movedbetween the peripheral portion and an optic portion to change an opticalparameter (e.g., power) of the intraocular lens.

The peripheral portions of the accommodating intraocular lensesdescribed herein are adapted so that at least a portion of theperipheral portions is less responsive, or less sensitive, to certaintypes of capsular forces than to other types of capsular forces. Lessresponsive, or less-sensitive, as used herein, generally means that theoptical power of the accommodating intraocular lens will change less inresponse to the types of forces to which the peripheral portion is lesssensitive than to other types of forces. In general, the peripheralportions are adapted to be less responsive to forces in theanterior-to-posterior direction than to forces in the radial direction.In some cases the forces in the anterior-to-posterior direction arenon-ciliary muscle related capsular forces, such as from size mismatchbetween the capsular bag and the intraocular lens, or from a capsularbag healing response. The radial forces as described herein are capsularreshaping and capsular forces resulting from ciliary muscle contractionand relaxation, causing accommodation of the accommodating intraocularlens. The accommodating intraocular lenses herein are thus considered tobe more sensitive to radial forces than to forces in theanterior-to-posterior direction, and thus the optical power of theaccommodating intraocular lens will change more in response to theradial forces than it will in response to forces in theanterior-to-posterior direction.

One of the benefits of the peripheral portions described herein is thatthey reshape the capsule, by essentially “propping” it open, in apredictable way while still preserving the radial sensitivity of theperipheral portion to radial forces to allow the accommodating lens toaccommodate. Variations in the base state of the accommodatingintraocular lens due to one or more of anatomical variations in capsulesize, inaccurate capsule measurements, or post-implant changes in thecapsule are reduced because the peripheral portion is adapted to morepredictably reshape the capsule in at least one direction. In someembodiments the peripheral portion is adapted to reshape the capsule ina more predictable way because it is stiffer in at least one direction.For example, in some embodiments the peripheral portion is stiffer inthe anterior-to-posterior direction than in the radial direction. Inthese embodiments the peripheral portion is adapted to prop open thecapsule in the anterior-to-posterior direction.

As used herein, “anterior-to-posterior,” or derivatives thereof, is notintended to be limited to the direction that is perfectly parallel tothe optical axis, but is interpreted to mean a direction that isgenerally in what is typically referred to as the anterior-to-posteriordirection. For example without limitation, the “anterior-to-posterior”direction includes directions or axes that are 10 degrees from theoptical axis of the accommodating intraocular lens. The “radial” forcesdescribed herein are not to be considered to be in theanterior-to-posterior direction.

FIG. 1A is a top view illustrating accommodating intraocular lens 10that includes optic portion 12 and a peripheral portion that in thisembodiment includes first and second haptics 14 coupled to and extendingperipherally from optic portion 12. Optic portion 12 is adapted torefract light that enters the eye onto the retina. Haptics 14 areconfigured to engage a capsular bag and are adapted to deform inresponse to ciliary muscle related capsular bag reshaping. FIG. 1B is aperspective view of intraocular lens 10 showing optic portion 12 andhaptics 14 coupled to optic portion 12.

The haptics are in fluid communication with the optic portion. Eachhaptic has a fluid chamber that is in fluid communication with an opticchamber in the optic portion. The haptics are formed of a deformablematerial and are adapted to engage the capsular bag and deform inresponse to ciliary muscle related capsular bag reshaping. When thehaptics deform the volume of the haptic fluid chamber changes, causing afluid disposed in the haptic fluid chambers and the optic fluid chamberto either move into the optic fluid chamber from the haptic fluidchambers, or into the haptic fluid chambers from the optic fluidchamber. When the volume of the haptic fluid chambers decreases, thefluid is moved into the optic fluid chamber. When the volume of thehaptic fluid chamber increases, fluid is moved into the haptic fluidchambers from the optic fluid chamber. The fluid flow into and out ofthe optic fluid chamber changes the configuration of the optic portionand the power of the intraocular lens.

FIG. 1C is a side sectional view through Section A-A indicated in FIG.1A. Optic portion 12 includes deformable anterior element 18 secured todeformable posterior element 20. Each haptic 14 includes a fluid chamber22 that is in fluid communication with optic fluid chamber 24 in opticportion 12. Only the coupling between the haptic 14 to the left in thefigure and option portion 12 is shown (although obscured) in thesectional view of FIG. 1C. The haptic fluid chamber 22 to the left inthe figure is shown in fluid communication with optic fluid chamber 24via two apertures 26, which are formed in posterior element 20. Thehaptic 14 to the right in FIG. 1C is in fluid communication with opticchamber 24 via two additional apertures also formed in posterior element(not shown) substantially 180 degrees from the apertures shown.

FIG. 1D is a top view of posterior element 20 (anterior element 18 andhaptics 14 not shown). Posterior element 20 includes buttress portions29 in which channels 32 are formed. Channels 32 provide fluidcommunication between optic portion 12 and haptics 14. Apertures 26 aredisposed at one end of channels 32. The optic fluid chamber 24 istherefore in fluid communication with a single haptic via two fluidchannels. Buttress portions 29 are configured and sized to be disposedwithin an opening formed in haptics 14 that defines one end of thehaptic fluid chamber, as described below. Each of buttress portions 29includes two channels formed therein. A first channel in a firstbuttress is in alignment with a first channel in the second buttress.The second channel in the first buttress is in alignment with the secondchannel in the second buttress.

There are advantages to having two channels in each buttress as opposedto one channel. A design with two channels rather than one channel helpsmaintain dimensional stability during assembly, which can be importantwhen assembling flexible and thin components. Additionally, it wasobserved through experimentation that some one-channel designs did notprovide adequate optical quality throughout the range of accommodation.In particular, lens astigmatism was observed in some one-channeldesigns, particularly as the intraocular lens accommodated. It wasdiscovered that the two-channel buttress designs described hereinreduced astigmatism, particularly as the lens accommodated. Astigmatismis reduced in these embodiments because the stiffness of the buttress isincreased by the rib portion between the two channels. The additionalstiffness results in less deflection due to pressure changes in thechannels. Less deflection due to the pressure changes in the channelsresults in less astigmatism. In some embodiments the channels arebetween about 0.4 mm and about 0.6 mm in diameter. In some embodimentsthe channels are about 0.5 mm in diameter. In some embodiments thedistance between the apertures is about 0.1 mm to about 1.0 mm.

FIG. 1E is a side assembly view through section A-A of optic portion 12,which includes anterior element 18 and posterior element 20 (haptics notshown for clarity). By including fluid channels 32 in posterior element20, posterior element 20 needs to have enough structure through whichthe channels 32 can be formed. Buttress portions 29 provide thatstructures in which channels 32 can be formed. At its peripheral-mostportion posterior element 20 is taller than anterior element 18 in theanterior-to-posterior direction. In alternative embodiments, thechannels can be formed in anterior element 18 rather than posteriorelement 20. The anterior element would include buttress portions 29 orother similar structure to provide structure in which the channels canbe formed. In these alternative embodiments the posterior element couldbe formed similarly to anterior element 18.

As shown in FIG. 1E, posterior element 20 is secured to anterior element18 at peripheral surface 28, which extends around the periphery ofposterior element 20 and is a flat surface. Elements 18 and 20 can besecured together using known biocompatible adhesives. Anterior element18 and posterior element 20 can also be formed from one material toeliminate the need to secure two elements together. In some embodimentsthe diameter of the region at which anterior element 18 and posteriorelement 20 are secured to one another is about 5.4 mm to about 6 mm indiameter.

In some embodiments the thickness of anterior element 18 (measured inthe anterior-to-posterior direction) is greater along the optical axis(“OA” in FIG. 1C) than at the periphery. In some embodiments thethickness increases continuously from the periphery towards the thickestportion along the optical axis.

In some embodiments the thickness of posterior element 20 decreases fromthe location along the optical axis towards the edge of central region“CR” identified in FIG. 1C. The thickness increases again radiallyoutward of central region CR towards the periphery, as can be seen inFIG. 1C. In some particular embodiments central region CR is about 3.75mm in diameter. The apertures are formed in beveled surface 30.

In some embodiments the thickness of posterior element 20 along theoptical axis is between about 0.45 mm and about 0.55 mm and thethickness at the periphery of posterior element 20 is between about 1.0mm and about 1.3.

In some embodiments the thickness of posterior element 20 along theoptical axis is about 0.5 mm and the thickness at the periphery ofposterior element 20 is about 1.14 mm.

In some embodiments the thickness of anterior element 18 along theoptical axis is between about 0.45 mm to about 0.55 mm, and in someembodiments is between about 0.50 mm to about 0.52 mm. In someembodiments the thickness at the periphery of anterior element 18 isbetween about 0.15 mm and about 0.4 mm, and in some embodiments isbetween about 0.19 mm and about 0.38 mm.

In one particular embodiment the thickness of anterior element 18 alongthe optical axis is about 0.52 mm and the thickness of the periphery ofanterior element 18 is about 0.38 mm, and the thickness of posteriorelement 20 along the optical axis is about 0.5 mm and the thickness atthe periphery of posterior element 20 is about 1.14 mm.

In one particular embodiment the thickness of anterior element 18 alongthe optical axis is about 0.5 mm and the thickness of the periphery ofanterior element 18 is about 0.3 mm, and the thickness of posteriorelement 20 along the optical axis is about 0.5 mm and the thickness atthe periphery of posterior element 20 is about 1.14 mm.

In one particular embodiment the thickness of anterior element 18 alongthe optical axis is about 0.51 mm and the thickness of the periphery ofanterior element 18 is about 0.24 mm, and the thickness of posteriorelement 20 along the optical axis is about 0.5 mm and the thickness atthe periphery of posterior element 20 is about 1.14 mm.

In one particular embodiment the thickness of anterior element 18 alongthe optical axis is about 0.52 mm and the thickness of the periphery ofanterior element 18 is about 0.19 mm, and the thickness of posteriorelement 20 along the optical axis is about 0.5 mm and the thickness atthe periphery of posterior element 20 is about 1.14 mm.

The optic portion is adapted to maintain optical quality throughoutaccommodation. This ensures that as the accommodating intraocular lenstransitions between the dis-accommodated and accommodatedconfigurations, the optic portion maintains optical quality. A number offactors contribute to this beneficial feature of the accommodatingintraocular lenses herein. These factors include the peripheral regionat which anterior element 18 is secured to posterior element 20, theshape profile of the anterior element 18 and posterior element 20 insidecentral region CR of the optic portion (see FIG. 1C), and the thicknessprofiles of anterior element 18 and posterior element 20. Thesecontributing factors ensure that both the anterior and posteriorelements flex in such a way as to maintain the shape necessary tomaintain optical quality across a range of optical powers.

FIG. 1F illustrates one haptic 14 from intraocular lens 10 (opticportion 12 and the second haptic not shown for clarity). Haptic 14includes radially outer portion 13 adapted to face the direction of thezonules, and radially inner portion 11, which faces the periphery of theoptic (not shown). Haptic 14 includes a first end region 17 which issecured to optic portion 12, and second end region 19 that is closed.Haptic 14 also includes opening 15 in first end region 17 that providesthe fluid communication with the haptic. In this embodiment opening 15is sized and configured to receive buttress portion 29 of optic portion12 therein.

FIG. 1G is a close up view of opening 15 in haptic 14, which is adaptedto receive buttress portion 29 therein. The opening 15 has curvedsurfaces 33 and 35 that are shaped to mate with curved surfaces on theoptic buttress 29. Surface 31 surrounds opening 15 and provides asurface to which a corresponding surface of the optic can be secured.

FIG. 1H is a top close up view of buttress portion 29 (in phantom) fromposterior element 20 disposed within opening 15 in haptic 14 (anteriorelement of the optic not shown for clarity). Channels 32 are shown inphantom. Haptic 14 includes fluid chamber 22 defined by inner surface21. Fluid moves between the optic fluid chamber and haptic fluid chamber22 through channels 32 upon the deformation of haptic 14.

FIG. 2A is a top view showing one haptic 14 shown in FIGS. 1A-1H. Theoptic portion and the second haptic are not shown. Four sections A-D areidentified through the haptic. FIG. 2B illustrates a side view of haptic14, showing opening 15 and closed end 19. FIG. 2C is a side view ofhaptic 14 showing radially outer portion 13 and closed end 19.

FIG. 2D is the cross sectional view through section A-A shown in FIG.2A. Of the four sections shown in FIG. 2A, section A-A is the sectionclosest to closed end 19. Radially inner portion 11 and radially outerportion 13 are identified. Fluid channel 22 defined by surface 21 isalso shown. In this section the radially inner portion 40 is radiallythicker (in the direction “T”) than radially outer portion 42. Innerportion 40 provides the haptic's stiffness in the anterior-to-posteriordirection that more predictably reshapes the capsule in theanterior-to-posterior direction. Radially inner portion 40 has agreatest thickness dimension 41, which is along an axis of symmetry inthis cross section. The outer surface of haptic 14 has a generallyelliptical configuration in which the greatest height dimension, in theanterior-to-posterior direction (“A-P”), is greater than the greatestthickness dimension (measured in the “T” dimension). The fluid chamber22 has a general D-shaped configuration, in which the radially innerwall 43 is less curved (but not perfectly linear) than radial outer wall45. Radially outer portion 42 engages the capsular bag where the zonulesattach thereto, whereas the thicker radially portion 40 is disposedadjacent the optic.

FIG. 2E illustrates section B-B shown in FIG. 2A. Section B-B issubstantially the same as section A-A, and FIG. 2E provides exemplarydimensions for both sections. Radially inner portion 40 has a greatestthickness along the midline of about 0.75 mm (in the radial direction“T”). Radially outer portion 42 has a thickness along the midline ofabout 0.24 mm. Fluid chamber 22 has a thickness of about 0.88 mm. Haptic14 has a thickness along the midline of about 1.87 mm. The height of thehaptic in the anterior to posterior dimension is about 2.97 mm. Theheight of the fluid chamber is about 2.60 mm. In this embodiment thethickness of the radially inner portion 40 is about 3 times thethickness of the radially outer portion 42. In some embodiments thethickness of the radially inner portion 40 is about 2 times thethickness of the radially outer portion 42. In some embodiments thethickness of the radially inner portion 40 is about 2 to about 3 timesthe thickness of the radially outer portion 42. In some embodiments thethickness of the radially inner portion 40 is about 1 to about 2 timesthe thickness of the radially outer portion 42.

Fluid chamber 22 is disposed in the radially outer portion of haptic 14.Substantially the entire radially inner region of haptic 14 in thissection is bulk material. Since the fluid chamber 22 is defined bysurfaces 43 and 45 (see FIG. 2D), the positioning and size of fluidchamber 22 depends on the thickness of the radially inner portion 40 andthe radially outer portion 42.

FIG. 2F illustrates Section C-C shown in FIG. 2A. In Section C-Cradially inner portion 40 is not as thick as radially inner portion 40in sections A-A and B-B, although in Section C-C radially inner portion40 is slightly thicker than radially outer portion 42. In thisparticular embodiment radially inner portion 40 is about 0.32 mm inSection C-C. Radially outer portion 42 has a thickness about the same asthe radially outer thickness in Sections A-A and B-B, about 0.24 mm. Theouter surface of haptic 14 does not have the same configuration as theouter surface in Sections A-A and Section B-B. In Section C-C theradially inner outer surface of haptic 51 is more linear than inSections A-A and Section B-B, giving the outer surface of haptic inSection C-C a general D-shape. In Section C-C fluid chamber 22 has ageneral D-shape, as in Sections A-A and Section B-B. The haptic, inSection C-C has a fluid chamber configuration that is substantially thesame as the fluid chamber configurations in Sections A-A and B-B, buthas an outer surface with a configuration different than theconfiguration of the outer surface of haptic 14 in Sections A-A and B-B.

The thinner radially inner portion 40 in Section C-C also creates accesspathways 23 that are shown in FIG. 1A. This space between optic portion12 and haptics 14 allows a physician to insert one or more irrigationand/or aspiration devices into space 23 during the procedure and applysuction to remove viscoelastic fluid that may be used in the delivery ofthe intraocular lens into the eye. The pathways 23 could also beanywhere along the length of the haptic, and there could be more thanone pathway 23. This application incorporates by reference thedisclosure in FIGS. 23 and 24, and the textual description thereof, fromU.S. Pub. No. 2008/0306588, which include a plurality of pathways in thehaptics.

FIG. 2G shows a view through Section D-D from FIG. 2A. Haptic 14includes opening 15 therein, which is adapted to receive the buttressfrom the optic portion as described herein. The height of opening 15 inthis embodiment is about 0.92 mm. The width, or thickness, of theopening is about 2.12 mm.

FIG. 3 illustrates relative diameters of optic portion 12 (not shown)and of the peripheral portion, which includes two haptics 14 (only onehaptic is shown). In this embodiment the optic has a diameter of about6.1 cm, while the entire accommodating intraocular lens, including theperipheral portion, has a diameter of about 9.95 cm. The dimensionsprovided are not intended to be strictly limiting.

FIG. 4 is a top view of haptic 14, showing that haptic 14 subtends anangle of about 175 degrees around optic (i.e., substantially 180degrees). The optic portion is not shown for clarity. The two hapticstherefore each subtend an angle of about 180 degrees around the optic. Afirst region 61 of haptic 14 is shown to subtend exemplary angle ofabout 118 degrees. This is the radially outermost portion of haptic 14,is adapted to engage the capsular bag, and is adapted to be mostresponsive to capsular shape changes. Region 61 can be thought of as themost responsive part of haptic 14.

The angle between Sections A-A and B-B, which are considered theboundaries of the stiffer radially inner portion of the haptic, is about40 degrees. The stiff radially inner portion of haptic 14 is positioneddirectly adjacent the periphery of the optic. The dimensions and anglesprovided are not intended to be strictly limiting.

FIGS. 5A and 5B illustrate a portion of accommodating intraocular lens10 positioned in a capsular bag (“CB”) after a native lens has beenremoved from the CB. The anterior direction is on top and the posteriordirection is on bottom in each figure. FIG. 5A shows the accommodatingintraocular lens in a lower power, or dis-accommodated, configurationrelative to the high power, or accommodated, configuration shown in FIG.5B.

The elastic capsular bag “CB” is connected to zonules “Z,” which areconnected to ciliary muscles “CM.” When the ciliary muscles relax, asshown in FIG. 5A, the zonules are stretched. This stretching pulls thecapsular bag in the generally radially outward direction due to radiallyoutward forces “R” due to the general equatorial connection locationbetween the capsular bag and the zonules. The zonular stretching causesa general elongation and thinning of the capsular bag. When the nativelens is still present in the capsular bag, the native lens becomesflatter (in the anterior-to-posterior direction) and taller in theradial direction, which gives the lens less power. Relaxation of theciliary muscle, as shown in FIG. 5A, provides for distance vision. Whenthe ciliary muscles contract, however, as occurs when the eye isattempting to focus on near objects, the radially inner portion of themuscles move radially inward, causing the zonules to slacken. This isillustrated in FIG. 5B. The slack in the zonules allows the capsular bagto move towards a generally more curved configuration in which theanterior surface has greater curvature than in the disaccommodatedconfiguration, providing higher power and allowing the eye to focus onnear objects. This is generally referred to as “accommodation,” and thelens is said to be in an “accommodated” configuration.

In section A-A (which is the same as section B-B) of haptic 14,illustrated in FIGS. 5A and 5B, radially inner portion 40 includesthicker bulk material that provides haptic 14 with stiffness in theanterior-to-posterior direction. When capsular bag forces are applied tothe haptic in the anterior-to-posterior direction, the inner portion 40,due to its stiffness, deforms in a more repeatable and predictablemanner making the base state of the lens more predictable. Additionally,the haptic, due to its stiffer inner portion, deforms the capsule in arepeatable way in the anterior-to-posterior direction. Additionally,because the haptic is less flexible along the length of the haptic, theaccommodating intraocular lens's base state is more predictable becausebending along the length of the haptic is one way in which fluid can bemoved into the optic (and thereby changing the power of the lens).Additional advantages realized with the stiffer inner portion are thatthe haptics are stiffer to other forces such as torqueing and splayingbecause of the extra bulk in the inner portion.

The radially outer portion 42 is the portion of the haptic that directlyengages the portion of the capsular bag that is connected to thezonules. Outer portion 42 of the haptics is adapted to respond tocapsular reshaping forces “R” that are applied generally radially whenthe zonules relax and stretch. This allows the haptic to deform inresponse to ciliary muscle related forces (i.e., capsular contractionand relaxation) so that fluid will flow between the haptic and the opticin response to ciliary muscle relaxation and contraction. This isillustrated in FIG. 5B. When the ciliary muscles contract (FIG. 5B), theperipheral region of the elastic capsular bag reshapes and appliesradially inward forces “R” on radially outer portion 42 of haptic 14.The radially outer portion 42 is adapted to deform in response to thiscapsular reshaping. The deformation decreases the volume of fluidchannel 22, which forces fluid from haptic chamber 22 into optic chamber24. This increases the fluid pressure in optic chamber 42. The increasein fluid pressure causes flexible anterior element 18 and flexibleposterior element 20 to deform, increasing in curvature, and thusincreasing the power of the intraocular lens.

The haptic is adapted to be stiffer in the anterior-to-posteriordirection than in the radial direction. In this embodiment the radiallyouter portion 42 of haptic 14 is more flexible (i.e., less stiff) in theradial direction than the stiffer inner portion 40 is in theanterior-to-posterior direction. This is due to the relative thicknessesof outer portion 42 and inner portion 40. The haptic is thus adapted todeform less in response to forces in the anterior-to-posterior directionthan to forces in the radial direction. This also causes less fluid tobe moved from the haptic into the optic in response to forces in theanterior-to-posterior direction than is moved into the optic in responseto forces in the radial direction. The haptic will also deform in a morepredictable and repeatable manner due to its stiffer radially innerportion.

The peripheral portion is thus more sensitive to capsular bag reshapingin the radial direction than to capsular bag reshaping in theanterior-to-posterior direction. The haptics are adapted to deform to agreater extent radially than they are in the anterior-to-posteriordirection. The disclosure herein therefore includes a peripheral portionthat is less sensitive to capsular forces along a first axis, but ismore sensitive to forces along a second axis. In the example above, theperipheral portion is less sensitive along the posterior-to-anterioraxis, and is more sensitive in the radial axis.

An exemplary benefit of the peripheral portions described above is thatthey deform the capsular bag in a repeatable way and yet maintain a highdegree of sensitivity to radial forces during accommodation. Theperipheral portions described above are stiffer in theanterior-to-posterior direction than in the radial direction.

An additional example of capsular forces in the anterior-to-posteriordirection is capsular forces on the peripheral portion after theaccommodating intraocular lens is positioned in the capsular bag, andafter the capsular bag generally undergoes a healing response. Thehealing response generally causes contraction forces on the haptic inthe anterior-to-posterior direction, identified in FIG. 5A by forces“A.” These and other post-implant, such as non-accommodating-related,capsular bag reshaping forces are described in U.S. application Ser. No.12/685,531, filed Jan. 11, 2010, which is incorporated herein byreference. For example, there is some patient to patient variation incapsular bag size, as is also described in detail in U.S. applicationSer. No. 12/685,531, filed Jan. 11, 2010. When an intraocular lens ispositioned within a capsular bag, size differences between the capsuleand intraocular lens may cause forces to be exerted on one or moreportions of the intraocular lens in the anterior-to-posterior direction.

In the example of capsular healing forces in the anterior-to-posteriordirection, the forces may be able to deform a deformable haptic beforeany accommodation occurs. This deformation changes the volume of thehaptic fluid chamber, causing fluid to flow between the optic fluidchamber and the haptic fluid chambers. This can, in some instancesundesirably, shift the base power of the lens. For example, fluid can beforced into the optic upon capsular healing, increasing the power of theaccommodating intraocular lens, and creating a permanent myopic shiftfor the accommodating intraocular lens. Fluid could also be forced outof the optic and into the haptics, decreasing the power of theaccommodating intraocular lens.

As used herein, “radial” need not be limited to exactly orthogonal tothe anterior-to-posterior plane, but includes planes that are 45 degreesfrom the anterior-to-posterior plane.

Exemplary fluids are described in U.S. application Ser. No. 12/685,531,filed Jan. 11, 2010, and in U.S. application Ser. No. 13/033,474, filedFeb. 23, 2011, now U.S. Pat. No. 8,900,298, which are incorporatedherein by reference. For example, the fluid can be a silicone oil thatis or is not index-matched with the polymeric materials of the anteriorand posterior elements. When using a fluid that is index matched withthe bulk material of the optic portion, the entire optic portion acts asingle lens whose outer curvature changes with increases and decreasesin fluid pressure in the optic portion.

In the embodiment in FIGS. 2A-2G above the haptic is a deformablepolymeric material that has a substantially uniform composition inSections A-A, B-B, and C-C. The stiffer radially inner body portion 40is attributed to its thickness. In alternative embodiments the radiallyinner body portion has a different composition that the outer bodyportion, wherein the radially inner body portion material is stifferthan the material of the radially outer body portion. In thesealternative embodiments the thicknesses of the radially inner and outerportions can be the same.

FIG. 6 illustrates haptic 50, which is the same haptic configuration asin shown in FIG. 2B. The radially outer portion 54 is identified. Thehaptic has axis A-A halfway through the height of the haptic. Opening52, in which the optic buttress is disposed, is on the posterior side ofaxis A. In this embodiment the optic sits slightly closer to theposterior-most portion of the haptics than the anterior-most portion ofthe haptics.

FIG. 7 illustrates an alternative haptic 60 (optic not shown), whereinthe radially outer portion 64 is identified. Haptic 60 includes axis A-Ahalfway through the thickness of the haptic. Opening 62 is symmetricalabout the axis A. Additionally, axis A-A is an axis of symmetry forhaptic 60. The symmetry of the haptic along axis A can improve theability to mold low relatively low stress components. FIG. 8 shows anembodiment of intraocular lens 70 in which the optic 72 is coupled totwo haptics 60, which are the haptics shown in FIG. 7. The optic sitsfurther in the anterior direction that in the embodiment in which theopening is not along the midline of the haptic. The cross sections A-A,B-B, and C-C of haptic 60 are the same as those shown in otherembodiments shown above.

FIG. 9 illustrates intraocular lens 80 including optic 82 and twohaptics 84. The optic is the same as the optic portions describedherein. Haptics 84 are not as tall, measured in theanterior-to-posterior direction, as haptic 60, haptic 50, or haptic 14.In exemplary embodiments haptics 84 are between about 2.0 mm and about3.5 mm tall, and in some embodiments they are about 2.8 mm tall.Intraocular lens 80 can be considered a size “small” accommodatingintraocular lens for patients with a capsular bag that is below acertain threshold size. The posterior surface of posterior element 86 isdisposed slightly further in the posterior direction than theposterior-most portions 90 of haptics 84.

Characteristics of the intraocular lenses described herein can similarlybe applied to non-fluid driven accommodating intraocular lenses. Forexample, a non-accommodating intraocular lens can include a peripheralportion with a first stiffer region that provides a region of theperipheral portion with an insensitivity in a first direction. Forexample, in an intraocular lens with two lenses adapted to be movedapart from one another to change the power of the lens, the peripheralportion of the lens can be adapted such that a first type of capsularreshaping does not cause the distance between the lenses to change, andthus the power of the intraocular lens stays the same.

Additionally, the accommodating intraocular lenses herein can also beadapted to be positioned outside of a native capsular bag. For example,the accommodating intraocular lenses can be adapted to be positioned infront of, or anterior to, the capsular bag after the native lens hasbeen removed or while the native lens is still in the capsular bag,wherein the peripheral portion of the lens is adapted to responddirectly with ciliary muscle rather than rely on capsular reshaping.

What is claimed is:
 1. An accommodating intraocular lens, comprising: an optic portion and a peripheral non-optic portion comprising a haptic, the haptic comprising a haptic fluid chamber in fluid communication with the optic portion, the haptic comprising a cross section in which a haptic fluid chamber radially inner wall defines a radially innermost wall of the peripheral non-optic portion and has a first wall thickness greater than a second wall thickness of a fluid chamber radially outer wall that defines a radially outermost wall of the peripheral non-optic portion, the first and second wall thicknesses measured along an axis orthogonal to an optical axis of the optic portion, and at a midpoint of a height dimension of the peripheral non-optic portion measured in a direction parallel to the optical axis, wherein the first wall thickness is greater than the second wall thickness along an entire height of the optic portion, wherein in the cross section the fluid chamber is defined by a single lumen, wherein the peripheral non-optic portion is, in the cross section, symmetrical about the axis that is orthogonal to the optical axis of the optic portion, and wherein the optic portion includes an anterior element and a posterior element, the anterior and posterior elements creating an optic fluid chamber in fluid communication with the haptic fluid chamber, and wherein the posterior element includes first and second apertures formed therein and extending radially outward, the first and second apertures, and no more than the first and second apertures, directly connecting the optic fluid chamber and the haptic fluid chamber.
 2. The accommodating intraocular lens of claim 1, wherein the peripheral portion further includes a second haptic extending from the optic portion.
 3. The accommodating intraocular lens of claim 1, wherein the anterior element is deformable in response to fluid movement between the haptic fluid chamber and the optic fluid chamber.
 4. The accommodating intraocular lens of claim 2, wherein the posterior element includes third and fourth apertures formed therein and extending radially outward, the third and fourth apertures directly connecting the optic fluid chamber and the second haptic fluid chamber. 